TDM-based Infliximab Treatment for Active Perianal Fistulizing Crohn's Disease

Recruiting Phase 4 Interventional Study
Crohn Disease Infliximab Perianal Fistula Due to Crohn's Disease Therapeutic Drug Monitoring Magnetic Resonance Novel Index for Fistula Imaging in Crohn's Disease Score
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
19 – 80
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
86 (estimated)
Sponsor
Asan Medical Center · Other
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About This Trial

This study will compare the efficacy and safety of TDM (therapeutic drug monitoring)-based infliximab (CT-P13, RemsimaTM) intravenous therapy compared with the standard infliximab (RemsimaTM) intravenous therapy for patients with active perianal fistulzing Crohn's disease.

Trial Locations
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Eligibility Criteria
* Inclusion Criteria: 1. Age: 19-80 years 2. Subjects diagnosed with perianal fistulizing Crohn's disease based on clinical, endoscopic, histological, and radiologic findings, etc. 3. Subjects naive to both biological drugs (anti-TNFs, anti-integrin, anti-IL12/23, etc.) and investigational ne…
Contacts

Byong Duk Ye, MD, PhD

82-2-3010-3181

bdye@amc.seoul.kr

CONTACT

Eun Ja Youn, RN

82-2-3010-8298

eunja.soul@gmail.com

CONTACT